Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
- Conditions
- Atrial Fibrillation
- Interventions
- Device: ICD with DX system
- Registration Number
- NCT02186704
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.
The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.
- Detailed Description
The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.
The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- Fulfills standard indications for ICD implantation
- Subject or legally authorized representative can provide written authorization per institutional requirements
- Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
- Able to comply with Home Monitoring
- Subject has prior diagnosis of atrial fibrillation or atrial flutter
- Subject has need for atrial pacing
- Subject unwilling or unable to give informed consent or participate in follow-up
- Subject is unable to comply with Home Monitoring
- Subject is pregnant
- Subject has less than one year estimated life expectancy
- Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
- Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICD with DX system ICD with DX system Implantable cardioverter-defibrillator recipients with DX system
- Primary Outcome Measures
Name Time Method Atrial High Rate Episode 1 year Atrial high rate episode \> 30 seconds in duration
- Secondary Outcome Measures
Name Time Method Atrial Sensing (DX System) 1 year P wave amplitudes measured by DX lead system
Trial Locations
- Locations (8)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Promedica Heart and Vascular Institute
🇺🇸Toledo, Ohio, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Ohio State Wexner University Medical Center
🇺🇸Columbus, Ohio, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States